Duns Number:109903521
Device Description: Navio Flat Markers
Catalog Number
PFSDV0016
Brand Name
Navio
Version/Model Number
PFSDV0016
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
OLO
Product Code Name
Orthopedic stereotaxic instrument
Public Device Record Key
cf81833c-7084-4f84-b5bd-b2001dae6c33
Public Version Date
October 16, 2018
Public Version Number
3
DI Record Publish Date
September 21, 2016
Package DI Number
40885556628902
Quantity per Package
10
Contains DI Package
30885556628905
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CAS
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 10651 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 35590 |
| 3 | A medical device with high risk that requires premarket approval | 351 |